R&D & Regulatory Systems Lead (Veeva Vault)

Viatris; United States; A distancia; USD 95.000 - 193.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote flexibility

Descripción de la vacante

Viatris is seeking an experienced R&D and Regulatory Systems Lead to work with Regulatory Affairs and R&D functions, focusing on Veeva RIM Vault configurations, integrations, and data migrations. This role requires strong technical oversight and cross-functional collaboration across global teams.

The position emphasizes ensuring compliance with FDA, EMA, and other health agencies, and leading technical design, deployments, and project management across initiatives.

Formación

• Bachelor’s degree in science, IT, or a related field.
• 10 years of Regulatory business process knowledge and hands-on experience configuring, migrating, and integrating Veeva Vaults.
• Experience with validated GxP environments, including Implementation, documentation, and change management is necessary.
• Hands on experience implementing, configuring, migrating and integrating Veeva Vault RIM platform including Registrations, Submissions & Archive Vaults (Required). Veeva certification desired.
• Broad technical knowledge, including hands on experience designing and implementing system integrations as well as working with migrations and SaaS in a regulated environment.

Responsabilidades

• Provide strong knowledge of the digital capabilities used to support global R&D business processes.
• Monitor emerging global health authority requirements to assess system impact and implement compliance.
• Translate user requirements into technical requirements and implement solutions according to industry best practices.
• Lead Veeva RIM Vault administration and development across deployments.
• Oversee end-to-end implementation of various R&D solutions with global teams and ensure regulatory compliance.

Conocimientos

Regulatory domain knowledge

Project management

Stakeholder communication

Regulatory systems

Agile methodologies

Educación

Bachelor’s degree in science, IT, or related field

Veeva RIM Vault certification preferred

Herramientas

Veeva RIM Vault

Vault API

Java

Python

Power BI

Descripción del empleo

Viatris is seeking an experienced R&D and Regulatory Systems Lead to work with Regulatory Affairs and R&D functions, focusing on Veeva RIM Vault configurations, integrations, and data migrations. This role requires strong technical oversight and cross-functional collaboration across global teams.

The position emphasizes ensuring compliance with FDA, EMA, and other health agencies, and leading technical design, deployments, and project management across initiatives.